Harvard Drug Research Fraud and Cover-up: How Off-Label Profiteering Works

The Harvard Drug Research Fraud and Cover-up: How Off-Label Profiteering Works

The recent disclosure that nearly 60% of the articles published by high-impact journals in all areas of medicine anphthalmitis have never been cited underscores just how much money is wasted on useless research. In the medical world, there are some journals who strangely charge authors to publish in their journal, and many journals who accept payment from drug companies to publish marketing materials disguised as "research." When you consider how political medical science has become with pharmaceuticals twisting studies for their own personal profits, it's no surprise that more than 50% of clinical trials go unpublished.

Many Americans are surprised to learn that the FDA requires all clinical trials be registered within 21 days of the first patient being dosed. The problem is, more than 50% of clinical trials remain unregistered. The Food and Drug Administration Amendments Act of 2007 was supposed to fix this problem by requiring registration within 21 days and by mandating posting of results within one year. However, as a recent report in JAMA noted: "FDA has not issued regulations that specify how sponsors should adhere to their postmarketing study registration and results reporting requirements." This is particularly concerning since pharmaceutical companies spend an estimated $24 billion per year on advertising, with about 80% directed at influencing doctors. There is little doubt that the pharmaceutical industry is using their money to influence doctors and politicians.

For example, former Governor of New York, David Paterson, received more than $1 million from drug and medical device companies while he was in office. In 2009-2010 he received almost $300,000 in campaign donations from the pharmaceutical industry. One of his biggest donors was Purdue Pharma who gave Paterson $5300 while they were at the same time lobbying him to fight against a lawsuit that had been brought against them for their role in the Oxycontin addiction epidemic in New York State. During this same time period Purdue Pharma was being sued by 26 states over their deceptive marketing practices. In July 2009, the Supreme Court of New York agreed to hear the case and companies such as Purdue Pharma were given the opportunity to pay for an expert witness who would testify for them. As it turns out, Paterson contacted the judge overseeing this case and said that he would agree not to appeal if Purdue Pharma gave him a $50,000 contribution on which his wife also received a $1000 commission. A contribution of this size could have made all the difference in this case because a decision against Purdue Pharma could have resulted in millions of dollars in damages.

Most recently, a major study of cancer survival published in JAMA found that patients who used complementary and alternative medical (CAM) treatments did worse than their counterparts who did not use these CAM treatments. The researchers suggested that this was probably due to the fact that these patients were more likely to use CAM treatments after they had failed conventional therapies. This is really just a fancy way of suggesting that using CAM therapies is useless and a waste of money. However, the real problem with this study was how it was funded by the National Center for Complementary and Alternative Medicine which is part of the National Institutes of Health (NIH). The NIH has very little funding and the vast majority of their funding goes to pharmaceutical companies. In fact, for 2015 the NIH received 52% of their budget from pharmaceutical company grants. Unfortunately, this translates into research that is skewed in favor of finding that pharmaceutical treatments are effective.

The other big problem with medical research is that it appears that studies which produce negative results are simply discarded and never published or if they do appear in a journal, they are seldom cited. One study published in BMJ Open suggested that a lot of research has simply been hidden from public view because when researchers looked for negative studies about drugs like Vioxx and antidepressants like Seroxat, the author could find no evidence of these studies being published.

Another recent study found that trials which were funded by companies that manufactured the drug were four times more likely to produce results suggesting that the drug worked. There are many other examples of how politics has trumped science in medical research. A systematic review of trials for antidepressants, for example, found that industry sponsored studies were about 5 times more likely to have results which favored the sponsor's product compared with non-industry sponsored studies.

There is also a growing body of evidence indicating that pharmaceutical companies systematically manipulate clinical trial data so they can win regulatory approval and then market their drugs for indications broader than those approved. For example, it is well known that pharmaceutical companies promote the use of certain drugs off-label but this is illegal. However, researchers at the Queensland University of Technology (QUT) in Australia found that the data for 31 studies for drugs like Vioxx and Seroxat did not match the results in clinical trials. The large difference is that off-label use almost always produced favorable results. In other words, off-label use was by far more effective than on-label use.

The QUT researchers found that whenever journal papers published drug company sponsored trials they would also include language suggesting they were worried about the possibility of bias and/or fraud by the competing drug company. In addition, they would also place "complex math statements" in their articles. These complex math statements would mean little to the average reader but they would be understandable to other researchers.

Most importantly, the QUT researchers found that whenever journal papers published drug company sponsored trials they would also include language suggesting they were worried about the possibility of bias and/or fraud by the competing drug company. In addition, they would also place "complex math statements" in their articles. These complex math statements would mean little to the average reader but they would be understandable to other researchers.

More recently, a systematic review of published trials for depression concluded that nearly 1 in 3 positive trial results could be explained by the use of imprecise methods in the analyses. These methods included the use of multiple endpoints, the use of high or very high study entry criteria, and under-reporting depression severity. In other words, it appears that there is a high probability that some drug companies have systematically manipulated research to make their products look better than they actually are. Another more recent meta-analysis showed that there was no significant difference between antidepressants and placebos except in studies funded by drug companies.

Conclusion

The bottom line is that pharmaceutical companies have a corporate mandate to make as much money as possible for their shareholders and therefore will do whatever it takes to increase their profits. To make this happen, they need the help of doctors. The most effective way to get doctors to prescribe more drugs is to increase their confidence in the drug's effectiveness and safety. The most effective way for drug companies to increase confidence in the effectiveness of their products is through positive clinical trial results. If a drug company cannot produce positive results during clinical trials, they will simply use any means necessary to convince people that these negative results are not relevant or that they are due to fraud or bias by competing companies.